Hugo Registry

JRCT ID: jRCT1042220132

Registered date:01/02/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Robot Assisted Surgery
• Date of first enrollment: 01/03/2023
• Target sample size: 450
• Countries of recruitment: Chile,Japan,India,Japan,Belgium,Japan,Denmark,Japan,Panama,Japan,Germany,Japan,Italy,Japan,France,Japan,Spain,Japan,Hongkong,Japan,Israel,Japan,Sweden,Japan,Netherlands,Japan,Switzerland,Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: The complication rate related to the Hugo RAS system and/or procedure
• Secondary Outcome: Additional information on the safety and performance of the Hugo RAS system (e.g. patient baseline characteristics, perioperative details, learning curve, robotic instruments used etc.)

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Patient or legally authorized representative (LAR) provides
authorization and/or consent per institution and geographical
requirements
- Patient has or is intended to receive or be treated with an eligible
Medtronic product
- Patient is consented within the enrollment window of the therapy received, as applicable

Exclude criteria

- Patient who is, or is expected to be, inaccessible for follow-up
- Patient is currently enrolled or plans to enroll in concurrent
drug/device study that may confound the PSR results

Related Information

• Primary Sponsor: Sekiguchi Yuta